FDA.reportPublic FDA data

RX Cleanse Hand Sanitizer

Manufacturer
360 Labs, Inc.
Effective date
2020-05-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:11:28

Label at a glance#

ProductRX Cleanse Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), Glycerin, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Peppermint Oil, Tea Tree Oil.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1GL RX Cleanse Hand Sanitizer1GL RX Cleanse Hand Sanitizer3.79L NDC: 74321-100-01

RX Cleanse Hand Sanitizer 70% Alcohol

Kills 99% of Germs and Bacteria

Made in a FDA Registered Facility

Warning: Flammable. Keep away from flame, keep out of eyes, for external use only. Keep out of reach from children. Do not store above 110 F

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74321-100-002022-01-28C16284748780-1d6a99b39-3d8e-a426-e053-dadaa90af4c2Rx Cleanse Hand Sanitizer - Sample Not for Resale
74321-100-012022-01-28C16284748780-1d6a99b39-3d8e-a426-e053-dadaa90af4c2Rx Cleanse Hand Sanitizer - Sample Not for Resale
74321-100-022022-01-28C16284748780-1d6a99b39-3d8e-a426-e053-dadaa90af4c2Rx Cleanse Hand Sanitizer - Sample Not for Resale
74321-100-052022-01-28C16284748780-1d6a99b39-3d8e-a426-e053-dadaa90af4c2Rx Cleanse Hand Sanitizer - Sample Not for Resale
74321-100-062022-01-28C16284748780-1d6a99b39-3d8e-a426-e053-dadaa90af4c2Rx Cleanse Hand Sanitizer - Sample Not for Resale
74321-100-082022-01-28C16284748780-1d6a99b39-3d8e-a426-e053-dadaa90af4c2Rx Cleanse Hand Sanitizer - Sample Not for Resale
74321-100-162022-01-28C16284748780-1d6a99b39-3d8e-a426-e053-dadaa90af4c2Rx Cleanse Hand Sanitizer - Sample Not for Resale
74321-100-552022-01-28C16284748780-1d6a99b39-3d8e-a426-e053-dadaa90af4c2Rx Cleanse Hand Sanitizer - Sample Not for Resale

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74321-100-00RX Cleanse Hand Sanitizer118.294 mL in 1 BOTTLEGEL118.2944
74321-100-01RX Cleanse Hand Sanitizer3785.41 mL in 1 BOTTLEGEL3785.414
74321-100-02RX Cleanse Hand Sanitizer59.1471 mL in 1 BOTTLEGEL59.14714
74321-100-05RX Cleanse Hand Sanitizer18927.1 mL in 1 BOTTLEGEL18927.14
74321-100-06RX Cleanse Hand Sanitizer177.441 mL in 1 POUCHGEL177.4414
74321-100-08RX Cleanse Hand Sanitizer236.588 mL in 1 BOTTLEGEL236.5884
74321-100-16RX Cleanse Hand Sanitizer473.176 mL in 1 BOTTLEGEL473.1764
74321-100-55RX Cleanse Hand Sanitizer208197.648 mL in 1 DRUMGEL208197.6484

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74321-100RX CLEANSE HAND SANITIZER (ALCOHOL) GEL [360 LABS, INC.]4Legacy NDC, 8 package rows20200515_a20b895a-3e72-7012-e053-2995a90a1ef4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74321-10074321-100-08, 74321-100-02, 74321-100-16, 74321-100-01, 74321-100-00, 74321-100-06, 74321-100-05, 74321-100-55

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
PEPPERMINT OILAV092KU4JHIACT
ALOE VERA LEAFZY81Z83H0XIACT
TEA TREE OILVIF565UC2GIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a58ed324-029b-12c2-e053-2a95a90af594a20b895a-3e72-7012-e053-2995a90a1ef42020-05-13WarningsExact identifier
spl id: a58ed324-029b-12c2-e053-2a95a90af594
spl set id: a20b895a-3e72-7012-e053-2995a90a1ef4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.